High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

NCT02960607 | Unknown Phase 2

• 1 other identifier: CH-L-059
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Progression Free survival

  2 years

Study Arms (1)

Icotinib

EXPERIMENTAL

250mg, tid until disease progression or unacceptable toxicities occurred

Drug: Icotinib

Interventions

Icotinib DRUG

Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.

Icotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed stage IIIB/IV NSCLC
• Investigator confirmed progression according RECIST 1.1 during previous icotinib treatment
• Patients whose tumors:
• are EGFR mutation-positive or
• T790M mutation-negative
• Performance status: WHO 0-2
• Measurable disease according to RECIST 1.1
• at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology
• a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm
• ANC ≥ 1.5\*109/L, Platelets ≥ 75\*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 × Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (\< 5 × ULN if liver metastases), Serum Creatinine ≤ 1.5 × ULN
• Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
• Patient must be able to comply with the protocol

You may not qualify if:

• Patient with symptomatic central nervous system metastases
• Patient has known active hepatitis B or C, or HIV infection
• Pregnant or breastfeeding.
• Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yutao Liu

CONTACT

13911901165@139.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 9, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2018
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

CN (1)